برجاء الإنتظار ...

Search Results



نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Cefaxon is an antibiotic given to adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

 

Cefaxon is used to treat infections of:

  • The brain (meningitis).
  • The lungs.
  • The middle ear.
  • The abdomen and abdominal wall (peritonitis).
  • The urinary tract and kidneys.
  • Bones and joints.
  • The skin or soft tissues.
  • The blood.
  • The heart.

 

It can be given:

  • To treat specific sexually transmitted infections (gonorrhoea and syphilis).
  • To treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection.
  • To treat infections of the chest in adults with chronic bronchitis.
  • To treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age.
  • To prevent infections during surgery.

You must not be given Cefaxon if:

  • You are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).
  • You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems or monobactams). The signs include sudden swelling of the throat or face which might make it difficult to breath or swallow, sudden swelling of the hands, feet and ankles, and a severe rash that develops quickly.
  • You are allergic to lidocaine and you are to be given Cefaxon as an injection into a muscle.

 

Cefaxon must not be given to babies if:

  • The baby is premature.
  • The baby is newborn (up to 28 days of age) and has certain blood problems or jaundice (yellowing of the skin or the whites of the eyes) or is to be given a product that contains calcium into their vein.

 

Warnings and precautions

Talk to your doctor or pharmacist or nurse before you are given Cefaxon if:

  • You have recently received or are about to receive products that contain calcium.
  • You have recently had diarrhoea after having an antibiotic medicine. You have ever had problems with your gut, in particular colitis (inflammation of the bowel).
  • You have liver or kidney problems (see section 4).
  • You have gall stones or kidney stones.
  • You have other illnesses, such as haemolytic anaemia (a reduction in your red blood cells that may make your skin pale yellow and cause weakness or breathlessness).
  • You are on a low sodium diet.
  • You experience or have previously experienced a combination of any of the following symptoms: rash, red skin, blistering of the lips eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

 

If you need a blood or urine test

If you are given Cefaxon for a long time, you may need to have regular blood tests. Cefaxon can affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are having tests:

  • Tell the person taking the sample that you have been given Cefaxon.

 

If you are diabetic or need to have your blood glucose level monitored you should not use certain blood glucose monitoring systems which may estimate blood glucose incorrectly while you are receiving ceftriaxone. If you use such systems check the instructions for use and tell your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

 

Children

Talk to your doctor or pharmacist or nurse before your child is administered Cefaxon if:

  • He/she has recently been given or is to be given a product that contains calcium into their vein.

 

Other medicines and Cefaxon

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • A type of antibiotic called an aminoglycoside.
  • An antibiotic called chloramphenicol (used to treat infections, particularly of the eyes).

 

Pregnancy, breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

 

The doctor will consider the benefit of treating you with Cefaxon against the risk to your baby.

 

Driving and using machines

Cefaxon can cause dizziness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience these symptoms.

 

Cefaxon contains sodium

Cefaxon contains sodium. Each vial of Cefaxon 500 mg and 1000 mg Powder for Solution for Injection contains 41.492 mg or 82.984 mg sodium (main component of cooking/table salt); respectively. This is equivalent to 2.1% or 4.1%; respectively of the recommended maximum daily dietary intake of sodium for an adult.


Cefaxon is usually given by a doctor or nurse. It can be given into a muscle.

 

Cefaxon is made up by the doctor, pharmacist or nurse and will not be mixed with or given to you at the same time as calcium-containing injections.

 

The usual dose

Your doctor will decide the correct dose of Cefaxon for you. The dose will depend on the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys and liver are working. The number of days or weeks that you are given Cefaxon depends on what sort of infection you have.

 

Adults, older people and children aged 12 years and over with a body weight greater than or equal to 50 kilograms (kg):

  • 1000 to 2000 mg once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose (up to 4000 mg once a day). If your daily dose is higher than 2000 mg, you may receive it as a single dose once a day or as two separate doses.

 

Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg:

  • 50-80 mg Cefaxon for each kg of the child’s body weight once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose up to 100 mg for each kg of body weight to a maximum of 4000 mg once a day. If your daily dose is higher than 2000 mg, you may receive it as a single dose once a day or as two separate doses.
  • Children with a body weight of 50 kg or more should be given the usual adult dose.

 

Newborn babies (0-14 days)

  • 20-50 mg Cefaxon for each kg of the child’s body weight once a day depending on the severity and type of infection.
  • The maximum daily dose is not to be more than 50 mg for each kg of the baby’s weight.

 

People with liver and kidney problems

You may be given a different dose to the usual dose. Your doctor will decide how much Cefaxon you will need and will check you closely depending on the severity of the liver and kidney disease.

 

If you are given more Cefaxon than you should

If you accidentally receive more than your prescribed dose, contact your doctor or nearest hospital straight away.

 

If you forget to use Cefaxon

If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to make up for a missed dose.

 

If you stop using Cefaxon

Do not stop taking Cefaxon unless your doctor tells you to.

 

If you have any further questions on the use of this medicine, ask your doctor or nurse.


Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

 

Treatment with ceftriaxone, particularly in elderly patients with serious kidney or nervous system problems may rarely cause decreased consciousness, abnormal movements, agitation and convulsions.

 

Severe allergic reactions (not known, frequency cannot be estimated from the available data)

If you have a severe allergic reaction, tell a doctor straight away.

 

The signs may include:

  • Sudden swelling of the face, throat, lips or mouth. This can make it difficult to breathe or swallow.
  • Sudden swelling of the hands, feet and ankles.

 

Severe skin reactions (not known, frequency cannot be estimated from the available data)

If you get a severe skin reaction, tell a doctor straight away.

 

The signs may include:

  • A severe rash that develops quickly, with blisters or peeling of the skin and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis which are also known as SJS and TEN).
  • A combination of any of the following symptoms: widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).
  • Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain, and skin rash that is usually self-limiting. This occurs shortly after starting ceftriaxone treatment for infections with spirochete such as Lyme disease.

 

Other possible side effects:

Common (may affect up to 1 in 10 people)

  • Abnormalities with your white blood cells (such as a decrease of leucocytes and an increase of eosinophils) and platelets (decrease of thrombocytes).
  • Loose stools or diarrhoea.
  • Changes in the results of blood tests for liver functions.
  • Rash.

 

Uncommon (may affect up to 1 in 100 people)

  • Fungal infections (for example, thrush or genital fungal infections).
  • A decrease in the number of white blood cells (granulocytopenia).
  • Reduction in number of red blood cells (anaemia).
  • Problems with the way your blood clots. The signs may include bruising easily and pain and swelling of your joints.
  • Headache.
  • Dizziness.
  • Feeling sick or being sick.
  • Pruritis (itching).
  • Pain or a burning feeling along the vein where ceftriaxone has been given. Blisters, deep redness or rash, burned areas, pain, irritation, itching at the injection site.
  • A high temperature (fever).
  • Abnormal kidney function test (blood creatinine increased).

 

Rare (may affect up to 1 in 1,000 people)

  • Inflammation of the large bowel (colon). The signs include diarrhoea, usually with blood and mucus, stomach pain and fever.
  • Difficulty in breathing (bronchospasm).
  • A lumpy rash (hives) that may cover a lot of your body, feeling itchy and swelling.
  • Blood or sugar in your urine.
  • Oedema (fluid build-up).
  • Shivering.

 

Not known (Frequency cannot be estimated from the available data)

  • A secondary infection that may not respond to the antibiotic previously prescribed.
  • Form of anaemia where red blood cells are destroyed (haemolytic anaemia).
  • Severe decrease in white blood cells (agranulocytosis).
  • Convulsions.
  • Vertigo (spinning sensation).
  • Inflammation of the pancreas (pancreatitis). The signs include severe pain in the stomach which spreads to your back.
  • Inflammation of the mucus lining of the mouth (stomatitis).
  • Inflammation of the tongue (glossitis). The signs include swelling, redness and soreness of the tongue.
  • Problems with your gallbladder and/or liver which may cause pain, nausea, vomiting, yellowing of the skin, itching, unusually dark urine and clay coloured stools.
  • A neurological condition that may occur in neonates with severe jaundice (kernicterus).
  • Kidney problems caused by deposits of calcium ceftriaxone. There may be pain when passing water (urine) or low output of urine.
  • A false positive result in a Coombs’ test (a test for some blood problems).
  • A false positive result for galactosaemia (an abnormal build up of the sugar galactose).
  • Cefaxon may interfere with some types of blood glucose tests - please check with your doctor.

 

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.


Keep this medicine out of the sight and reach of children.

Store below 25°C.

Store in the original package in order to protect from light.

Chemical and physical in-use stability of the reconstituted product and diluted solution has been demonstrated for at least 6 hours at or below 25°C or 24 hours at 2-8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than the times stated above for the chemical and physical in-use stability.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


The active substance is ceftriaxone sodium.

 

Each vial of Cefaxon 500 mg Powder for Solution for Injection contains 596.5 mg ceftriaxone sodium equivalent to 500 mg ceftriaxone.

 

Each vial of Cefaxon 1000 mg Powder for Solution for Injection contains 1193 mg ceftriaxone sodium equivalent to 1000 mg ceftriaxone.

 

There are no other ingredients.


Cefaxon 500 mg Powder for Solution for Injection is an almost white or yellowish crystalline powder in colorless sealed vials with royal blue caps. Cefaxon 1000 mg Powder for Solution for Injection is an almost white or yellowish crystalline powder in colorless sealed vials with white caps. After reconstitution, the color of solutions ranges from pale yellow to amber. Pack size: 1 Vial and 1 Solvent ampoule (5 ml of 1% lidocaine hydrochloride).

Marketing Authorization Holder

Jazeera Pharmaceutical Industries
Al-Kharj Road
P.O. Box 106229
Riyadh 11666, Saudi Arabia
Tel: + (966-11) 8107023, + (966-11) 2142472
Fax: + (966-11) 2078170
e-mail: SAPV@hikma.com

 

Manufacturer

Hikma Farmaceutica (Portugal), S.A.

Estrada do Rio Da Mó,

n.°8, 8A e 8B, Fervença

2705-906 Terrugem

Sintra, Portugal

Tel: + (351-2) 19608410

Fax: + (351-2) 19615102

 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can also help provide more information on the safety of this medicine.

  • Saudi Arabia

The National Pharmacovigilance Centre (NPC)

SFDA Call Center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa

  • Other GCC States

Please contact the relevant competent authority.


This leaflet was last revised in 11/2023; version number SA3.0.
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

سيفاكسون هو مضاد حيوي يعطى للبالغين والأطفال (بما في ذلك الأطفال حديثي الولادة) وهو يعمل عن طريق قتل البكتيريا التي تسبب الالتهابات. ينتمي إلى مجموعة من الأدوية تسمى السيفالوسبورينات.

 

يستخدم سيفاكسون لعلاج التهابات:

  • الدماغ (السحايا).
  • الرئتين.
  • الأذن الوسطى.
  • جدار البطن والبطن (التهاب الصفاق).
  • المسالك البولية والكلى.
  • العظام والمفاصل.
  • الجلد أو الأنسجة الرخوة.
  • الدم.
  • القلب.

 

يمكن أن يعطى:

  • لعلاج التهابات محددة والتي تنتقل عن طريق الاتصال الجنسي (السيلان والزهري).
  • لعلاج المرضى الذين يعانون من انخفاض تعداد خلايا الدم البيضاء (العدلات) والذين يعانون من حمى بسبب عدوى بكتيرية.
  • لعلاج التهابات الصدر لدى البالغين الذين يعانون من التهاب الشعب الهوائية المزمن.
  • لعلاج مرض لايم (الناجم عن لدغات القراد) لدى البالغين والأطفال بما في ذلك الأطفال حديثي الولادة بعمر 15 يوم.
  • للوقاية من العدوى أثناء الجراحة.

لا يجب إعطاؤك سيفاكسون إذا:

  • كنت تعاني من حساسية من سيفترياكسون أو أي من المكونات الأخرى لهذا الدواء (المذكورة في القسم 6).
  • حصل لديك رد فعل مفاجئ أو رد فعل حساسية شديد للبنسلين أو المضادات الحيوية المماثلة (مثل السيفالوسبورينات، أو الكاربابينيمات أو البيتا لاكتامات الأحادية). وتشمل العلامات تورم مفاجئ في الحلق أو الوجه والذي قد يجعل من التنفس أو البلع صعباً، تورم مفاجئ في اليدين والقدمين والكاحلين، والطفح الجلدي الشديد الذي يتطور بسرعة.
  • كنت تعاني من حساسية من ليدوكائين وستعطى سيفاكسون كحقنة في العضل.

 

يجب ألا يعطى سيفاكسون للرضع إذا:

  • كان الطفل خديج (ولد قبل موعده).
  • كان الطفل حديث الولادة (بعمر أقل من أو يساوي 28 يوم) ويعاني من مشاكل معينة في الدم أو اليرقان (اصفرار الجلد أو اصفرار بياض العينين) أو سيعطى المنتجات التي تحتوي على الكالسيوم في الوريد.

 

الاحتياطات والتحذيرات

تحدث مع طبيبك، الصيدلي أو الممرض قبل أن يتم إعطاؤك سيفاكسون. في الحالات التالية إذا:

  • كنت قد تلقيت مؤخراً أو أنت على وشك أن تتلقى المنتجات التي تحتوي على الكالسيوم.
  • عانيت مؤخراً من الإسهال بعد تناول مضاداً حيوياً. إذا عانيت في أي وقت مضى من مشاكل في أمعائك، وخصوصاً التهاب القولون (التهاب الأمعاء).
  • كنت تعاني من مشاكل في الكبد أو الكلى (انظر القسم 4).
  • كنت تعاني من حصى المرارة أو حصى الكلى.
  • كنت تعاني من أمراض أخرى، مثل فقر الدم الانحلالي (انخفاض في خلايا الدم الحمراء التي قد تجعل بشرتك شاحبة بلون أصفر وتسبب ضعفاً عاماً أو ضيقاً في التنفس).
  • كنت تسير على حمية قليلة الصوديوم.
  • كنت تعاني أو سبق لك أن عانيت من أي مجموعة من الأعراض التالية: طفح واحمرار الجلد ووجود بثور على الشفتين، العينين والفم وتقشر الجلد وحمى شديدة وأعراض تشبه الأنفلونزا وزيادة مستويات إنزيمات الكبد في فحوصات الدم وزيادة في أحد أنواع خلايا الدم البيضاء (كثرة اليوزينيات) وتضخم الغدد الليمفاوية (علامات ردود فعل جلدية حادة، انظر أيضاً القسم 4 "الآثار الجانبية المحتملة").

 

إذا كنت بحاجة لإجراء فحص الدم أو البول

قد تحتاج إلى إجراء فحوصات الدم بانتظام إذا تم إعطاؤك سيفاكسون لفترة طويلة. يمكن أن يؤثر سيفاكسون على نتائج فحوصات البول لفحص السكر وفحص الدم المعروف باسم فحص كومبز.إذا كنت ستقوم بفحوصات:

  • أخبر الشخص الذي سيأخذ العينة أنه قد تم إعطاؤك سيفاكسون.

 

إذا كنت مصاب بالسكري أو تحتاج لمراقبة كمية الغلوكوز في الدم يجب عليك عدم استخدام أجهزة معينة لمراقبة كمية الغلوكوز في الدم والتي من الممكن أن تقدر غلوكوز الدم بطريقة غير صحيحة خلال فترة تناولك سيفترياكسون، إذا كنت تستخدم أجهزة كهذه تأكد من تعليمات الاستخدام وأخبر طبيبك، الصيدلي أو الممرض. يجب استخدام طرق بديلة إذا كان ذلك ضرورياً

 

الأطفال

تحدث إلى طبيبك أو الصيدلي أو الممرض قبل أن يعطى سيفاكسون لطفلك، إذا:

  • أعطي/ أعطيت في الآونة الأخيرة أو سيعطى منتجات تحتوي على الكالسيوم في الوريد.

 

الأدوية الأخرى وسيفاكسون

أخبر طبيبك أو الصيدلي إذا كنت تتناول أو تناولت مؤخراً أية أدوية أخرى.

 

أخبر طبيبك أو الصيدلي إذا كنت تتناول أي من الأدوية التالية على وجه الخصوص

  • نوع من المضادات الحيوية والمسمى أمينوغليكوزيد.
  • نوع من المضادات الحيوية والمسمى الكلورامفينيكول (يستخدم لعلاج الالتهابات، وخاصة في العينين).

 

الحمل والرضاعة

يرجى استشارة طبيبك إذا كنت حاملاً أو مرضعة، تعتقدين أنك حاملاً أو تخططين لذلك. استشيري طبيبك من أجل النصيحة قبل تناول هذا الدواء.

 

سوف يقوم الطبيب بتقييم مدى الاستفادة من علاجك بسيفاكسون مقابل المخاطر التي قد يتعرض لها طفلك.

 

القيادة واستخدام الآلات

يمكن أن يتسبب سيفاكسون بشعور بالدوار. إذا شعرت بالدوار، لا تقم بالقيادة أو استخدام أي أدوات أو آلات. تحدث مع طبيبك إذا واجهت هذه الأعراض.

 

يحتوي سيفاكسون على الصوديوم

يحتوي سيفاكسون على الصوديوم. تحتوي كل زجاجة من سيفاكسون 500 ملغم و1000 ملغم مسحوق للحل للحقن على 41.492 ملغم أو 82.984 ملغم صوديوم (المكون الأساسي في الطبخ/ملح الطعام)؛ على التوالي. وهذا يكافئ 2,1% أو 4.1%؛ على التوالي من الجرعة اليومية القصوى الموصى بها من الصوديوم للبالغين.

https://localhost:44358/Dashboard

عادة ما يعطى سيفاكسون من قبل طبيب أو ممرضة. يمكن أن يعطى في العضل.


تحضر جرعة سيفاكسون من قبل الطبيب أو الصيدلي أو الممرضة ولن يخلط مع أو يعطى لك في نفس الوقت الذي تعطى فيه حقن أخرى تحتوي على الكالسيوم.

 

الجرعة الاعتيادية:

سوف يقرر الطبيب الجرعة الصحيحة المناسبة لك من سيفاكسون. تعتمد الجرعة على شدة ونوع العدوى، وما إذا كنت تتناول أي من المضادات الحيوية الأخرى، وعلى وزنك، وعمرك؛ وصحة عمل الكليتين والكبد لديك. سيعتمد عدد الأيام أو الأسابيع التي سيعطى لك سيفاكسون فيها على نوع العدوى التي لديك.

 

البالغين والمسنين والأطفال الذين يبلغون من العمر 12 سنة فما فوق مع والذين يزنون أكثر من أو يساوي 50 كغم:

  • 2000-1000 ملغم مرة واحدة يومياً تبعا لشدة ونوع العدوى. إذا كنت تعاني من عدوى شديدة، فسوف يعطيك طبيبك جرعة أعلى (تصل إلى 4000 ملغم مرة واحدة في اليوم). إذا كانت الجرعة اليومية أعلى من 2000 ملغم، فقد تتلقاها كجرعة واحدة مرة واحدة في اليوم أو كجرعتين منفصلتين.

 

الأطفال حديثي الولادة والرضع والأطفال الذين تتراوح أعمارهم بين 15 يوم إلى 12 سنة والذين يزنون أقل من 50 كغم:

  • 80-50 ملغم من سيفاكسون لكل كيلوغرام من وزن الجسم مرة واحدة يومياً تبعا لشدة ونوع العدوى. إذا كان لديه عدوى شديدة، فسوف يعطيه الطبيب جرعة أعلى تصل إلى 100 ملغم لكل كيلوغرام من وزن الجسم لكمية أقصاها 4000 ملغم مرة واحدة يومياً. إذا كانت الجرعة اليومية أكبر من 2000 ملغم، فقد تعطى كجرعة واحدة مرة واحدة في اليوم أو كجرعتين منفصلتين.
  • يعطى الأطفال الذين يزنون 50 كغم أو أكثر الجرعة المعتادة للبالغين.

 

الأطفال حديثي الولادة (0-14 يوم)

  • 50-20 ملغم من سيفاكسون لكل كيلوغرام من وزن الجسم مرة واحدة يوميا تبعاً لشدة ونوع العدوى.
  • الجرعة اليومية القصوى لا يجب أن تكون أكثر من 50 ملغم لكل كيلوغرام من وزن الطفل.

 

المرضى الذين يعانون من مشاكل في الكبد والكلى

قد تعطى جرعة مختلفة عن الجرعة المعتادة. سوف يقرر طبيبك كمية سيفاكسون التي تحتاجها وسوف يقوم بفحصك بدقة وفق شدة مرض الكبد والكلى لديك.

 

إذا تم إعطاؤك سيفاكسون أكثر من اللازم

إذا أعطيت جرعة زائدة بالخطأ. اتصل مع طبيبك أو أقرب مركز طوارئ على الفور.

 

إذا نسيت استخدام سيفاكسون

إذا فوتّ حقنة، يجب أن تأخذها في أقرب وقت ممكن. ومع ذلك، إذا كنت على مقربة من الجرعة القادمة، فتجاوز الحقنة التي فوتها. لا تأخذ جرعة مضاعفة (حقنتين في نفس الوقت) لتعويض الجرعة المنسية.

 

إذا توقفت عن استخدام سيفاكسون

لا تتوقف عن استخدام سيفاكسون ما لم يخبرك الطبيب بذلك.

 

إذا كان لديك أي أسئلة إضافية حول استخدام هذا الدواء، اسأل الطبيب، الصيدلي أو الممرض.

مثل جميع الأدوية، قد يسبب هذا الدواء آثاراً جانبيةً، إلا أنه ليس بالضرورة أن تحدث لدى جميع مستخدمي هذا الدواء. قد تحصل الأعراض الجانبية التالية:

 

قد يسبب العلاج بسيفترياكسون انخفاض الوعي وحدوث حركات غير طبيعية وتهيج وتشنجات في حالات نادرة، وبخاصة مع المرضى كبار السن الذين يعانون من مشكلات خطيرة في الكُلى أو الجهاز العصبي.

 

رد فعل تحسسي شديد (غير معروف، لا يمكن تقدير التكرار من البيانات المتاحة).

إذا عانيت من رد فعل تحسسي شديد، أخبر الطبيب على الفور.

 

ويمكن أن تشتمل أعراض رد الفعل التحسسي على:

  • تورم مفاجئ في الوجه، الحلق، الشفاه أو الفم. يمكن أن يجعل ذلك التنفس أو البلع صعباً.
  • تورم مفاجئ في اليدين، القدمين والكاحلين.

 

ردود فعل جلدية حادة (غير معروف، لا يمكن تقدير التكرار من البيانات المتاحة)

أبلغ الطبيب على الفور إذا كنت تعاني من طفح جلدي حاد.

 

قد تشمل العلامات:

  • طفح جلدي حاد يتطور سريعاً مع ظهور بثور أو تقشر في الجلد، وقد تظهر البثور أيضاً بالفم (متلازمة ستيفنز جونسون وتقشر الأنسجة المتموتة البشروية التسممي)
  • الإصابة بأي مجموعة من الأعراض التالية: انتشار الطفح الجلدي وارتفاع درجة حرارة الجسم وارتفاع إنزيمات الكبد وتشوهات دموية (كثرة اليوزينيات) وتضخم العقد الليمفاوية ووجود مشكلات في أعضاء الجسم الأخرى (التفاعل الدوائي مع اليوزينيات ومع أعراض شاملة والمعروفة كذلك باسم متلازمة فرط الحساسية للدواء).
  • تفاعل جاريش هركسايمر الذي يسبب حمى وقشعريرة وصداع وألم بالعضلات وطفح جلدي يكون في العادة ذاتي الشفاء. يحدث هذا بعد فترة قصيرة من بدء العلاج بسفترياكسون لحالات العدوى بالبكتيريا الملتوية مثل داء لايم.

 

الآثار الجانبية المحتملة الأخرى:

شائعة (قد تؤثر فيما يصل إلى شخص من بين كل 10 أشخاص)

  • شذوذ في خلايا الدم البيضاء (مثل انخفاض الكريات البيضاء وزيادة الحمضات) وفي الصفائح الدموية (نقص الصفيحات).
  • براز رخو أو إسهال.
  • تغيرات في نتائج فحوصات الدم لوظائف الكبد.
  • الطفح الجلدي.

 

غير شائعة (قد تؤثر فيما يصل إلى شخص من بين كل 100 شخص)

  • العدوى الفطرية (على سبيل المثال، القلاع).
  • انخفاض في عدد خلايا الدم البيضاء (المحببات).
  • انخفاض في عدد خلايا الدم الحمراء (فقر الدم).
  • مشاكل في طريقة تجلط الدم. يمكن أن تشمل الأعراض حدوث كدمات بسهولة وألم وتورم في المفاصل.
  • صداع.
  • دوخة.
  • الشعور بالغثيان أو التقيؤ.
  • الحكة.
  • ألم أو شعور بحرقة على طول الوريد حيث تم إعطاء سيفترياكسون. بثور، احمرار عميق أو طفح، مناطق محروقة، ألم، تهيج وحكة في موضع الحقن.
  • ارتفاع في درجة الحرارة (حمى).
  • اختلال في فحص وظائف الكلى (زيادة الكرياتينين في الدم).

 

نادرة (قد تؤثر فيما يصل إلى شخص من بين كل 1000 شخص)

  • التهاب الأمعاء الغليظة (القولون). وتشتمل الأعراض الإسهال، وعادة ما يكون مصحوباً بالدم والمخاط، وآلام في المعدة وحمى.
  • صعوبة في التنفس (تشنج قصبي).
  • طفح جلدي عقدي (الشرى) والذي قد يغطي مساحة كبيرة من الجسم، الشعور بالحكة والتورم.
  • الدم أو السكر في البول.
  • وذمة (تراكم السوائل).
  • الرعاش.

 

غير معروف (لا يمكن تقدير التكرار من البيانات المتاحة)

  • عدوى ثانوية قد لا تستجيب للمضادات الحيوية الموصوفة سابقاً.
  • شكل من أشكال فقر الدم حيث يتم تدمير خلايا الدم الحمراء (فقر الدم الانحلالي).
  • انخفاض حاد في خلايا الدم البيضاء (ندرة المحببات).
  • تشنجات.
  • دوار.
  • التهاب البنكرياس. وتشتمل الأعراض آلاماً حادةً في المعدة تمتد إلى الظهر.
  • التهاب بطانة الفم المخاطية (التهاب الفم).
  • التهاب اللسان. وتشتمل الأعراض التورم والاحمرار وألم حاد في اللسان.
  • مشاكل في المرارة و/أو الكبد والتي قد تسبب الألم، الشعور بالغثيان، التقيؤ، اصفرار الجلد، حكة، بول داكن بشكل غير عادي وبراز بلون الطين.
  • مشاكل عصبية قد تحدث لدى حديثي الولادة ممن يعانون من اليرقان الشديد (اليرقان النووي).
  • مشاكل في الكلى ناتجة عن ترسبات سيفترياكسون الكالسيوم. قد يكون هناك ألم عند التبول أو انخفاض في إنتاج البول.
  • نتيجة إيجابية خاطئة في فحص كومبز (فحص بعض مشاكل الدم).
  • نتيجة إيجابية خاطئة لوجود الجلاكتوز في الدم (بناء الجلاكتوز بطريقة غير طبيعية).
  • قد يتداخل سيفاكسون مع بعض أنواع فحوصات السكر في الدم- يرجى مراجعة طبيبك.

 

راجع طبيبك أو الصيدلي إذا ساءت أية من هذه الآثار الجانبية أو لاحظت ظهور أية آثار جانبية غير مدرجة في هذه النشرة.

احفظ هذا الدواء بعيداً عن مرأى ومتناول الأطفال.

يحفظ عند درجة حرارة أقل من 25° مئوية.

يحفظ داخل العبوة الأصلية للحماية من الضوء.

تم إثبات الاستقرار الكيميائي والفيزيائي خلال فترة الاستخدام للمستحضر المحضر والمحلول المخفف لمدة لا تقل عن 6 ساعات عند درجة حرارة 25° مئوية أو أقل أو لمدة 24 ساعة عند درجة حرارة 2-8° مئوية.

من وجهة النظر الميكروبيولوجية، يجب استخدام المستحضر على الفور. في حال عدم استخدامه على الفور، تقع مسؤولية فترات التخزين أثناء الاستخدام وظروف التخزين قبل الاستخدام على المستخدم ولا يجب أن تكون المدة أطول من المدة المذكورة أعلاه في دراسات الاستقرار الكيميائي والفيزيائي خلال فترة الاستخدام.

لا تستخدم هذا الدواء بعد تاريخ انتهاء الصلاحية المذكور على العبوة الخارجية بعد "EXP". يشير تاريخ انتهاء الصلاحية إلى اليوم الأخير من ذلك الشهر.

لا تستخدم هذا الدواء إذا لاحظت أي علامات تلف واضحة عليه.

لا تتخلص من أي أدوية عن طريق مياه الصرف الصحي أو النفايات المنزلية. اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد بحاجة إليها. هذه الإجراءات ستساعد في الحفاظ على سلامة البيئة.

المادة الفعالة هي سيفترياكسون الصوديوم.

 

تحتوي كل زجاجة من سيفاكسون 500 ملغم مسحوق للحل للحقن على 596.5 ملغم سيفترياكسون الصوديوم يكافئ 500 ملغم سيفترياكسون.

 

تحتوي كل زجاجة من سيفاكسون 1000 ملغم مسحوق للحل للحقن على 1193 ملغم سيفترياكسون الصوديوم يكافئ 1000 ملغم سيفترياكسون.

 

لا يوجد مكونات أخرى.

سيفاكسون 500 ملغم مسحوق للحل للحقن هو مسحوق بلوري لونه أبيض تقريباً أو أصفر في زجاجات عديمة اللون مع أغطية ذات لون أزرق نيلي.

 

سيفاكسون 1000 ملغم مسحوق للحل للحقن هو مسحوق بلوري لونه أبيض تقريباً إلى أصفر في زجاجات عديمة اللون مع أغطية ذات لون أبيض.

 

بعد الحلّ، يتراوح لون المحلول من الأصفر الباهت إلى اللون الكهرماني.

 

حجم العبوة: زجاجة واحدة وأمبولة مذيب واحدة (5 مللتر من 1% هيدروكلوريد الليدوكايين).

 

مالك رخصة التسويق

شركة الجزيرة للصناعات الدوائية
طريق الخرج
صندوق بريد 106229
الرياض 11666، المملكة العربية السعودية
هاتف: 8107023 (11-966) +، 2142472 (11-966) +
فاكس: 2078170 (11-966) +
البريد الإلكتروني: SAPV@hikma.com

 

الشركة المصنعة

شركة أدوية الحكمة (البرتغال)، المساهمة العامة المحدودة
إسترادا دو ريو دا مو،

مبنى رقم ، فارفانسا
2705-906 تيروجيم

سنترا، البرتغال
هاتف: 19608410 (2-351) +
فاكس: 19615102 (2-351) +

  

للإبلاغ عن الأعراض الجانبية

تحدث إلى الطبيب، الصيدلي، أو الممرض إذا عانيت من أية آثار جانبية. وذلك يشمل أي آثار جانبية لم يتم ذكرها في هذه النشرة. كما أنه يمكنك الإبلاغ عن هذه الآثار مباشرةً (انظر التفاصيل المذكورة أدناه). من خلال الإبلاغ عن الآثار الجانبية، يمكنك المساعدة بتوفير معلومات مهمة عن سلامة الدواء.

  • المملكة العربية السعودية

المركز الوطني للتيقظ الدوائي

مركز الاتصال الموحد: 19999

البريد الإلكتروني: npc.drug@sfda.gov.sa

الموقع الإلكتروني:  https://ade.sfda.gov.sa

  • دول الخليج العربي الأخرى

الرجاء الاتصال بالجهات الوطنية في كل دولة.

تمت مراجعة هذه النشرة بتاريخ 11/2023؛ رقم النسخة SA3.0.
 Read this leaflet carefully before you start using this product as it contains important information for you

Cefaxon 500 mg Powder for Solution for Injection

Each vial of Cefaxon 500 mg Powder for Solution for Injection contains 596.5 mg ceftriaxone sodium equivalent to 500 mg ceftriaxone. Excipient with known effect: Sodium. For the full list of excipients, see section 6.1.

Powder for solution for injection. Cefaxon 500 mg Powder for Solution for Injection is an almost white or yellowish crystalline powder. After reconstitution, the color of solution ranges from pale yellow to amber.

Cefaxon is indicated for the treatment of the following infections in adults and children including term neonates (from birth):

  • Bacterial Meningitis
  • Community acquired pneumonia
  • Hospital acquired pneumonia
  • Acute otitis media
  • Intra-abdominal infections
  • Complicated urinary tract infections (including pyelonephritis)
  • Infections of bones and joints
  • Complicated skin and soft tissue infections
  • Gonorrhoea
  • Syphilis
  • Bacterial endocarditis

 

Cefaxon may be used:

  • For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults
  • For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age
  • For Pre-operative prophylaxis of surgical site infections
  • In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection
  • In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above

 

Cefaxon should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4).

 

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.


Posology

The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient.

 

The doses recommended in the tables below are the generally recommended doses in these indications. In particularly severe cases, doses at the higher end of the recommended range should be considered.

 

Adults and children over 12 years of age (≥ 50 kg)

Ceftriaxone Dosage*

Treatment frequency**

Indications

1000-2000 mg

Once daily

Community acquired pneumonia

Acute exacerbations of chronic obstructive pulmonary disease

Intra-abdominal infections

Complicated urinary tract infections (including pyelonephritis)

2000 mg

Once daily

Hospital acquired pneumonia

Complicated skin and soft tissue infections

Infections of bones and joints

2000-4000 mg

Once daily

Management of neutropenic patients with fever that is suspected to be due to a bacterial infection

Bacterial endocarditis

Bacterial meningitis

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

** Twice daily (12 hourly) administration may be considered where doses greater than 2000 mg daily are administered.

 

Indications for adults and children over 12 years of age (≥ 50 kg) that require specific dosage schedules:

Acute otitis media

A single intramuscular dose of ceftriaxone 1000-2000 mg can be given.

 

Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, ceftriaxone may be effective when given as an intramuscular dose of 1000-2000 mg daily for 3 days.

 

Pre-operative prophylaxis of surgical site infections

2000 mg as a single pre-operative dose.

 

Gonorrhoea

500 mg as a single intramuscular dose.

 

Syphilis

The generally recommended doses are 500 mg-1000 mg once daily increased to 2000 mg once daily for neurosyphilis for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on limited data. National or local guidance should be taken into consideration.

 

Disseminated Lyme borreliosis (early [Stage II] and late [Stage III])

2000 mg once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.

 

Paediatric population

Neonates, infants and children 15 days to 12 years of age (< 50 kg)

For children with bodyweight of 50 kg or more, the usual adult dosage should be given.

Ceftriaxone dosage*

Treatment frequency**

Indications

50-80 mg/kg

Once daily

Intra-abdominal infections

Complicated urinary tract infections (including pyelonephritis)

Community acquired pneumonia

Hospital acquired pneumonia

50-100 mg/kg (Max 4000 mg)

Once daily

Complicated skin and soft tissue infections

Infections of bones and joints

Management of neutropenic patients with fever that is suspected to be due to a bacterial infection

80-100 mg/kg (max 4000 mg)

Once daily

Bacterial meningitis

100 mg/kg (max 4000 mg)

Once daily

Bacterial endocarditis

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

** Twice daily (12 hourly) administration may be considered where doses greater than 2000 mg daily are administered.

 

Indications for infants and children 15 days to 12 years (< 50 kg) that require specific dosage schedules:

 

Acute otitis media

For initial treatment of acute otitis media, a single intramuscular dose of Cefaxon 50 mg/kg can be given. Limited data suggest that in cases where the child is severely ill or initial therapy has failed, Cefaxon may be effective when given as an intramuscular dose of 50 mg/kg daily for 3 days.

 

Pre-operative prophylaxis of surgical site infections

50-80 mg/kg as a single pre-operative dose.

 

Syphilis

The generally recommended doses are 75-100 mg/kg (max 4000 mg) once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.

 

Disseminated Lyme borreliosis (early [Stage II] and late [Stage III])

50–80 mg/kg once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.

 

Neonates 0-14 days

Ceftriaxone is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).

Ceftriaxone dosage*

Treatment frequency

Indications

20-50 mg/kg

Once daily

Intra-abdominal infections

Complicated skin and soft tissue infections

Complicated urinary tract infections (including pyelonephritis)

Community acquired pneumonia

Hospital acquired pneumonia

Infections of bones and joints

 

Management of neutropenic patients with fever that is suspected to be due to a bacterial infection

50 mg/kg

Once daily

Bacterial meningitis

Bacterial endocarditis

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

A maximum daily dose of 50 mg/kg should not be exceeded.

 

Indications for infants and children 15 days to 12 years (< 50 kg) that require specific dosage schedules:

Acute otitis media

For initial treatment of acute otitis media, a single intramuscular dose of Cefaxon 50 mg/kg can be given.

 

Pre-operative prophylaxis of surgical site infections

20-50 mg/kg as a single pre-operative dose.

 

Syphilis

The generally recommended dose is 50 mg/kg once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.

 

Duration of therapy

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of Cefaxon should be continued for 48 - 72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved.

 

Older people

The dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory.

 

Patients with hepatic impairment

Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment provided renal function is not impaired.

 

There are no study data in patients with severe hepatic impairment (see section 5.2).

 

Patients with renal impairment

In patients with impaired renal function, there is no need to reduce the dosage of Cefaxon provided hepatic function is not impaired. Only in cases of preterminal renal failure (creatinine clearance < 10 ml/min) should the Cefaxon dosage not exceed 2000 mg daily.

 

In patients undergoing dialysis no additional supplementary dosing is required following the dialysis.  

 

Ceftriaxone is not removed by peritoneal- or haemodialysis. Close clinical monitoring for safety and efficacy is advised.

 

Patients with severe hepatic and renal impairment

In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised.

 

Method of administration

Intramuscular administration

Cefaxon can be administered by deep intramuscular injection. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1000 mg should be injected at one site.

 

As the solvent used is lidocaine, the resulting solution should never be administered intravenously (see section 4.3). The information in the Summary of Product Characteristics of lidocaine should be considered.

 

Intravenous administration

Intramuscular administration should be considered when the intravenous route is not possible or less appropriate for the patient. For doses greater than 2000 mg intravenous administration should be used.

 

For pre-operative prophylaxis of surgical site infections, Cefaxon should be administered 30-90 minutes prior to surgery.

 

For instructions on reconstitution of the medicinal product before administration, see section 6.6.


Hypersensitivity to ceftriaxone or to any other cephalosporin. History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems). Cefaxon is contraindicated in: • Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)* • Full-term neonates (up to 28 days of age): - With hyperbilirubinaemia, jaundice, or who are hypoalbuminaemic or acidotic because these are conditions in which bilirubin binding is likely to be impaired* * In vitro studies have shown that ceftriaxone can displace bilirubin from its serum albumin binding sites leading to a possible risk of bilirubin encephalopathy in these patients. Contraindications to lidocaine must be excluded before intramuscular injection of Cefaxon when lidocaine solution is used as a solvent (see section 4.4). See information in the Summary of Product Characteristics of lidocaine, especially contraindications. Cefaxon solutions containing lidocaine should never be administered intravenously.

Hypersensitivity reactions

As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported (see section 4.8). In case of severe hypersensitivity reactions, treatment with Cefaxon must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftriaxone, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if Cefaxon is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.

 

Severe cutaneous adverse reactions (Stevens Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS)) which can be life-threatening or fatal have been reported in association of ceftriaxone treatment; however, the frequency of these events is not known (see section 4.8).

 

Paediatric population

Safety and effectiveness of ceftriaxone in neonates, infants and children have been established for the dosages described under Posology and Method of Administration (see section 4.2). Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin.

 

Cefaxon is contraindicated in premature and full-term neonates at risk of developing bilirubin encephalopathy (see section 4.3).

 

Immune mediated haemolytic anaemia

An immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class antibacterials including ceftriaxone (see section 4.8). Severe cases of haemolytic anaemia, including fatalities, have been reported during ceftriaxone treatment in both adults and children.

 

If a patient develops anaemia while on Cefaxon, the diagnosis of a cephalosporin-associated anaemia should be considered and Cefaxon discontinued until the aetiology is determined.

 

Long term treatment

During prolonged treatment complete blood count should be performed at regular intervals.

 

Colitis/Overgrowth of non-susceptible microorganisms

Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of Cefaxon (see section 4.8). Discontinuation of therapy with Cefaxon and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

 

Superinfections with non-susceptible micro-organisms may occur as with other antibacterial agents.

 

Severe renal and hepatic insufficiency

In severe renal and hepatic insufficiency, close clinical monitoring for safety and efficacy is advised (see section 4.2).

 

Interference with serological testing

Interference with Coombs tests may occur, as Cefaxon may lead to false-positive test results.

 

Cefaxon can also lead to false-positive test results for galactosaemia (see section 4.8).

 

Non-enzymatic methods for the glucose determination in urine may give false-positive results. Urine glucose determination during therapy with Cefaxon should be done enzymatically (see section 4.8).

 

The presence of ceftriaxone may falsely lower estimated blood glucose values obtained with some blood glucose monitoring systems. Please refer to instructions for use for each system. Alternative testing methods should be used if necessary.

 

Sodium

Cefaxon contains sodium. Each vial of Cefaxon 500 mg Powder for Solution for Injection contains 41.492 mg sodium (main component of cooking/table salt). This is equivalent to 2.1% of the recommended maximum daily dietary intake of sodium for an adult.

 

Antibacterial spectrum

Ceftriaxone has a limited spectrum of antibacterial activity and may not be suitable for use as a single agent for the treatment of some types of infections unless the pathogen has already been confirmed (see section 4.2). In polymicrobial infections, where suspected pathogens include organisms resistant to Cefaxon, administration of an additional antibiotic should be considered.

 

Use of lidocaine

In case a lidocaine solution is used as a solventCefaxon solutions must only be used for intramuscular injection. Contraindications to lidocaine, warnings and other relevant information as detailed in the Summary of Product Characteristics of lidocaine must be considered before use (see section 4.3). The lidocaine solution should never be administered intravenously.

 

Biliary lithiasis

When shadows are observed on sonograms, consideration should be given to the possibility of precipitates of calcium-ceftriaxone. Shadows, which have been mistaken for gallstones, have been detected on sonograms of the gallbladder and have been observed more frequently at ceftriaxone doses of 1000 mg per day and above. Caution should be particularly considered in the paediatric population. Such precipitates disappear after discontinuation of ceftriaxone therapy. Rarely precipitates of calcium-ceftriaxone have been associated with symptoms. In symptomatic cases, conservative nonsurgical management is recommended and discontinuation of ceftriaxone treatment should be considered by the physician based on specific benefit risk assessment (see section 4.8).

 

Biliary stasis

Cases of pancreatitis, possibly of biliary obstruction aetiology, have been reported in patients treated with ceftriaxone (see section 4.8). Most patients presented with risk factors for biliary stasis and biliary sludge e.g. preceding major therapy, severe illness and total parenteral nutrition. A trigger or cofactor of ceftriaxone-related biliary precipitation cannot be ruled out.

 

Renal lithiasis

Cases of renal lithiasis have been reported, which is reversible upon discontinuation of ceftriaxone (see section 4.8). In symptomatic cases, sonography should be performed. Use in patients with history of renal lithiasis or with hypercalciuria should be considered by the physician based on specific benefit risk assessment.

 

Jarisch-Herxheimer reaction (JHR)

Some patients with spirochete infections may experience a Jarisch-Herxheimer reaction (JHR) shortly after ceftriaxone treatment is started. JHR is usually a self - limiting condition or can be managed by symptomatic treatment. The antibiotic treatment should not be discontinued if such reaction occurs.

 

Encephalopathy

Encephalopathy has been reported with the use of ceftriaxone (see section 4.8), particularly in elderly patients with severe renal impairment (see section 4.2) or central nervous system disorders. If ceftriaxone-associated encephalopathy is suspected (e.g. decreased level of consciousness, altered mental state, myoclonus, convulsions), discontinuation of Cefaxon should be considered.


Concomitant use with oral anticoagulants may increase the anti-vitamin K effect and the risk of bleeding. It is recommended that the International Normalised Ratio (INR) is monitored frequently and the posology of the anti-vitamin K drug adjusted accordingly, both during and after treatment with Cefaxon (see section 4.8).

 

There is conflicting evidence regarding a potential increase in renal toxicity of aminoglycosides when used with cephalosporins. The recommended monitoring of aminoglycoside levels (and renal function) in clinical practice should be closely adhered to in such cases.

 

In an in-vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone. The clinical relevance of this finding is unknown.

 

There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (intravenous or oral).

 

In patients treated with ceftriaxone, the Coombs' test may lead to false-positive test results.

 

Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosaemia.

 

Likewise, non-enzymatic methods for glucose determination in urine may yield false-positive results. For this reason, glucose level determination in urine during therapy with Cefaxon should be carried out enzymatically.

 

No impairment of renal function has been observed after concurrent administration of large doses of ceftriaxone and potent diuretics (e.g. furosemide).

 

Simultaneous administration of probenecid does not reduce the elimination of ceftriaxone.


Pregnancy

Ceftriaxone crosses the placental barrier. There are limited amounts of data from the use of ceftriaxone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal, perinatal and postnatal development (see section 5.3). Ceftriaxone should only be administered during pregnancy and in particular in the first trimester of pregnancy if the benefit outweighs the risk.

 

Breastfeeding

Ceftriaxone is excreted into human milk in low concentrations but at therapeutic doses of ceftriaxone no effects on the breastfed infants are anticipated. However, a risk of diarrhoea and fungal infection of the mucous membranes cannot be excluded. The possibility of sensitisation should be taken into account. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ceftriaxone therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

 

Fertility

Reproductive studies have shown no evidence of adverse effects on male or female fertility.


During treatment with Cefaxon, undesirable effects may occur (e.g. dizziness), which may influence the ability to drive and use machines (see section 4.8). Patients should be cautious when driving or operating machinery.

 


The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased.

 

Data to determine the frequency of ceftriaxone ADRs was derived from clinical trials.

 

The following convention has been used for the classification of frequency:

Very common (≥ 1/10)

Common (≥ 1/100 - < 1/10)

Uncommon (≥ 1/1000 - < 1/100)

Rare (≥ 1/10000 - < 1/1000)

Not known (cannot be estimated from the available data)

 

System Organ Class

Common

Uncommon

Rare

Not Known a

Infections and infestations

 

Genital fungal infection

Pseudo-membranous colitisb

Superinfectionb

Blood and lymphatic system disorders

Eosinophilia Leucopenia

Thrombocytopenia

Granulocytopenia

Anaemia

Coagulopathy

 

Haemolytic anaemiab

Agranulocytosis

Immune system disorders

   

Anaphylactic shock

Anaphylactic reaction

Anaphylactoid reaction

Hypersensitivityb

Jarisch-Herxheimer reactionb

Nervous system disorders

 

Headache

Dizziness

Encephalopathy

Convulsion

Ear and labyrinth disorders

   

Vertigo

Respiratory, thoracic and mediastinal disorders

  

Bronchospasm

 

Gastrointestinal disorders

Diarrhoeab

Loose stools

Nausea

Vomiting

 

Pancreatitisb

Stomatitis

Glossitis

Hepatobiliary disorders

Hepatic enzyme increased

  

Gall bladder precipitationb

Kernicterus

Hepatitisc

Hepatitis cholestaticb,c

Skin and subcutaneous tissue disorders

Rash

Pruritus

Urticaria

Stevens Johnson Syndromeb

Toxic epidermal necrolysisb

Erythema multiforme

Acute generalised exanthematous pustulosis

Drug reaction with eosinophilia and systemic symptoms (DRESS)b

Renal and urinary disorders

  

Haematuria

Glycosuria

Oliguria

Renal precipitation (reversible)

General disorders and administration site conditions

 

Phlebitis

Injection site reaction

Pyrexia

Oedema

Chills

 

Investigations

 

Blood creatinine increased

 

Coombs test false positiveb

Galactosaemia test false positiveb

Non enzymatic methods for glucose determination false positiveb

Based on post-marketing reports. Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.

b See section 4.4

c Usually reversible upon discontinuation of ceftriaxone

 

 

Description of selected adverse reactions

Infections and infestations

Reports of diarrhoea following the use of ceftriaxone may be associated with Clostridium difficile. Appropriate fluid and electrolyte management should be instituted (see section 4.4)

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

  • Saudi Arabia

The National Pharmacovigilance Centre (NPC)

SFDA Call Center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa

 

  • Other GCC States

Please contact the relevant competent authority.


In overdose, the symptoms of nausea, vomiting and diarrhoea can occur. Ceftriaxone concentrations cannot be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdose should be symptomatic.


Pharmacotherapeutic group: Antibacterials for systemic use, Third-generation cephalosporins, ATC code: J01DD04

 

Mode of action

Ceftriaxone inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

 

Resistance

Bacterial resistance to ceftriaxone may be due to one or more of the following mechanisms:

  • Hydrolysis by beta-lactamases, including extended-spectrum beta-lactamases (ESBLs), carbapenemases and Amp C enzymes that may be induced or stably derepressed in certain aerobic Gram-negative bacterial species.
  • Reduced affinity of penicillin-binding proteins for ceftriaxone.
  • Outer membrane impermeability in Gram-negative organisms.
  • Bacterial efflux pumps.

 

Susceptibility testing breakpoints

Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:

Pathogen

Dilution Test

(MIC, mg/L)

Susceptible

Resistant

Enterobacteriaceae

≤ 1

> 2

Staphylococcus spp.

a.

a.

Streptococcus spp.

(Groups A, B, C and G)

b.

b.

Streptococcus pneumoniae

≤ 0.5c.

> 2

Viridans group Streptococci

≤0.5

>0.5

Haemophilus influenzae

≤ 0.12c.

> 0.12

Moraxella catarrhalis

≤ 1

> 2

Neisseria gonorrhoeae

≤ 0.12

> 0.12

Neisseria meningitidis

≤ 0.12 c.

> 0.12

Non-species related

≤ 1d.

> 2

a. Susceptibility inferred from cefoxitin susceptibility.

b. Susceptibility inferred from penicillin susceptibility.

c. Isolates with a ceftriaxone MIC above the susceptible breakpoint are rare and, if found, should be re-tested and, if confirmed, should be sent to a reference laboratory.

d. Breakpoints apply to a daily intravenous dose of 1000 mg x 1 and a high dose of at least 2000 mg x 1.

 

Clinical efficacy against specific pathogens

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of ceftriaxone in at least some types of infections is questionable.

Commonly susceptible species

Gram-positive aerobes

Staphylococcus aureus (methicillin-susceptible)£

Staphylococci coagulase-negative (methicillin-susceptible)£

Streptococcus pyogenes (Group A)

Streptococcus agalactiae (Group B)

Streptococcus pneumoniae

Viridans Group Streptococci

Gram-negative aerobes

Borrelia burgdorferi

Haemophilus influenzae

Haemophilus parainfluenzae

Moraxella catarrhalis

Neisseria gonorrhoea

Neisseria meningitidis

Proteus mirabilis

Providencia spp.

Treponema pallidum

Species for which acquired resistance may be a problem

Gram-positive aerobes

Staphylococcus epidermidis+

Staphylococcus haemolyticus+

Staphylococcus hominis+

Gram-negative aerobes

Citrobacter freundii

Enterobacter aerogenes

Enterobacter cloacae

Escherichia coli%

Klebsiella pneumoniae%

Klebsiella oxytoca%

Morganella morganii

Proteus vulgaris

Serratia marcescens

Anaerobes

Bacteroides spp.

Fusobacterium spp.

Peptostreptococcus spp.

Clostridium perfringens

Inherently resistant organisms

Gram-positive aerobes

Enterococcus spp.

Listeria monocytogenes

Gram-negative aerobes

Acinetobacter baumannii

Pseudomonas aeruginosa

Stenotrophomonas maltophilia

Anaerobes

Clostridium difficile

Others:

Chlamydia spp.

Chlamydophila spp.

Mycoplasma spp.

Legionella spp.

Ureaplasma urealyticum

£ All methicillin-resistant staphylococci are resistant to ceftriaxone.

Resistance rates >50% in at least one region

ESBL producing strains are always resistant


Absorption

Intramuscular administration

Following intramuscular injection, mean peak plasma ceftriaxone levels are approximately half those observed after intravenous administration of an equivalent dose. The maximum plasma concentration after a single intramuscular dose of 1000 mg is about 81 mg/l and is reached in 2 - 3 hours after administration.

 

The area under the plasma concentration-time curve after intramuscular administration is equivalent to that after intravenous administration of an equivalent dose.

 

Distribution

The volume of distribution of ceftriaxone is 7 – 12 l. Concentrations well above the minimal inhibitory concentrations of most relevant pathogens are detectable in tissue including lung, heart, biliary tract/liver, tonsil, middle ear and nasal mucosa, bone, and in cerebrospinal, pleural, prostatic and synovial fluids. An 8 - 15% increase in mean peak plasma concentration (Cmax) is seen on repeated administration; steady state is reached in most cases within 48 - 72 hours depending on the route of administration.

 

Penetration into particular tissues

Ceftriaxone penetrates the meninges. Penetration is greatest when the meninges are inflamed. Mean peak ceftriaxone concentrations in CSF in patients with bacterial meningitis are reported to be up to 25% of plasma levels compared to 2% of plasma levels in patients with uninflamed meninges.  Peak ceftriaxone concentrations in CSF are reached approximately 4-6 hours after intravenous injection. Ceftriaxone crosses the placental barrier and is excreted in the breast milk at low concentrations (see section 4.6).

 

Protein binding

Ceftriaxone is reversibly bound to albumin. Plasma protein binding is about 95 % at plasma concentrations below 100 mg/l. Binding is saturable and the bound portion decreases with rising concentration (up to 85% at a plasma concentration of 300 mg/l).

 

Biotransformation

Ceftriaxone is not metabolised systemically; but is converted to inactive metabolites by the gut flora.

 

Elimination

Plasma clearance of total ceftriaxone (bound and unbound) is 10 - 22 ml/min. Renal clearance is 5 - 12 ml/min. 50 - 60% of ceftriaxone is excreted unchanged in the urine, primarily by glomerular filtration, while 40 - 50% is excreted unchanged in the bile. The elimination half-life of total ceftriaxone in adults is about 8 hours.

 

Patients with renal or hepatic impairment

In patients with renal or hepatic dysfunction, the pharmacokinetics of ceftriaxone are only minimally altered with the half-life slightly increased (less than two fold), even in patients with severely impaired renal function.

 

The relatively modest increase in half-life in renal impairment is explained by a compensatory increase in non-renal clearance, resulting from a decrease in protein binding and corresponding increase in non-renal clearance of total ceftriaxone.

 

In patients with hepatic impairment, the elimination half-life of ceftriaxone is not increased, due to a compensatory increase in renal clearance. This is also due to an increase in plasma free fraction of ceftriaxone contributing to the observed paradoxical increase in total drug clearance, with an increase in volume of distribution paralleling that of total clearance.

 

Older people

In older people aged over 75 years the average elimination half-life is usually two to three times that of young adults.

 

Paediatric population

The half-life of ceftriaxone is prolonged in neonates. From birth to 14 days of age, the levels of free ceftriaxone may be further increased by factors such as reduced glomerular filtration and altered protein binding. During childhood, the half-life is lower than in neonates or adults.

 

The plasma clearance and volume of distribution of total ceftriaxone are greater in neonates, infants and children than in adults.

 

Linearity/non-linearity

The pharmacokinetics of ceftriaxone are non-linear and all basic pharmacokinetic parameters, except the elimination half-life, are dose dependent if based on total drug concentrations, increasing less than proportionally with dose. Non-linearity is due to saturation of plasma protein binding and is therefore observed for total plasma ceftriaxone but not for free (unbound) ceftriaxone.

 

Pharmacokinetic/pharmacodynamic relationship

As with other beta-lactams, the pharmacokinetic-pharmacodynamic index demonstrating the best correlation with in vivo efficacy is the percentage of the dosing interval that the unbound concentration remains above the minimum inhibitory concentration (MIC) of ceftriaxone for individual target species (i.e. %T > MIC).


There is evidence from animal studies that high doses of ceftriaxone calcium salt led to formation of concrements and precipitates in the gallbladder of dogs and monkeys, which proved to be reversible. Animal studies produced no evidence of toxicity to reproduction and genotoxicity. Carcinogenicity studies on ceftriaxone were not conducted.

 


There are no other ingredients.


Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.

 

If treatment with a combination of another antibiotic with Cefaxon is intended, administration should not occur in the same syringe or in the same infusion solution.

 

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.


Unopened vials: 36 months. Chemical and physical in-use stability of the reconstituted product and diluted solution has been demonstrated for at least 6 hours at or below 25°C or 24 hours at 2-8°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than the times stated above for the chemical and physical in-use stability.

Store below 25°C.

 

Store in the original package in order to protect from light.

 

For storage conditions of the reconstituted medicinal product, see section 6.3.


Colorless sealed vials with royal blue caps.

 

Pack size: 1 Vial and 1 Solvent ampoule (5 ml of 1% lidocaine HCl).


Preparation of solutions for injection

The use of freshly prepared solutions is recommended. For storage conditions of the reconstituted medicinal product, see section 6.3.

 

Cefaxon should not be mixed in the same syringe with any drug other than 1% lidocaine HCl solution (for intramuscular injection only).

 

Cefaxon 500 mg Powder for Solution for Injection

For IM injection 500 mg Cefaxon is dissolved in 2 ml of 1% lidocaine HCl solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1000 mg should be divided and injected at more than one site.

 

The displacement volume of 500 mg of Cefaxon is 0.36 ml in 1% lidocaine HCl solution. When adding 2 ml of 1% lidocaine HCl solution, the final concentration of the reconstituted solution is 211.86 mg/ml.

 

Any unused product or waste material should be disposed of in accordance with local requirements.


Jazeera Pharmaceutical Industries Al-Kharj Road P.O. Box 106229 Riyadh 11666, Saudi Arabia Tel: + (966-11) 8107023, + (966-11) 2142472 Fax: + (966-11) 2078170 e-mail: SAPV@hikma.com

22 November 2023
}

صورة المنتج على الرف

الصورة الاساسية